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NCT03614143 Clinical Trial

Biomarker Study for Prediction of aGVHD

aGVHD Clinical Trial

Official title:
Biomarker Identification for aGVHD After Allogeneic Stem Cell Transplantation: a Multiple Center Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03614143
Other study ID # SHTG-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2016
Est. completion date July 2020

Study information
Verified date August 2018
Source Shanghai Jiao Tong University School of Medicine
Contact Jiong HU, M.D.
Phone 86-21-64370045
Email hj10709@rjh.com.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.

Description:

This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- all patients undergoing allogeneic stem cel transplantation

- with informed consent

- patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD

Exclusion Criteria:

- patients with blood sample and clinical data not available

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of grade II-IV aGVHD clinical diagnosis and grade of aGVHD 100 days after allogeneic stem cell tansplantation
See also
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Recruiting NCT05214066 - Efficacy and Safety Study of 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT Phase 2
Completed NCT04061876 - First Line Therapy for High Risk Acute GVHD Phase 2
Recruiting NCT05263999 - A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR) Phase 3